Use of Ortho Evra Patch Backed by FDA Advisory Panel

Last week, an FDA advisory panel voted 19 to 5 that the Ortho Evra birth control patch should remain on the market, finding that its benefits outweigh its potential risk for blood clots. While the panel’s final vote ultimately backed the continued use of the patch, it also recommended that information regarding the increased risk for blood clots be clearly stated on the product’s label.

More specifically, members of the Advisory Committee for Reproductive Health Drugs, along with members of a Drug Safety Committee, on Friday voted to recommend to the FDA that the agency allow the Ortho Evra norelgetromin/ethinyl estradiol transdermal patch to remain a contraceptive option for women who cannot or do not take birth control pills at the same time each day.

Ironically, this same panel convened the previous day and voted (15 to 11) that the benefits of drospirenone-containing birth control pills like Yaz also outweigh the risk for blood clots, or venous thromboembolism (VTE).

While Ortho Evra does not contain drospirenone, it does contain higher levels of estrogen compared to older birth control options. Moreover, an FDA postmarketing report released in October revealed that the patch, the vaginal ring and birth control pills containing drospirenone were all linked to a higher risk for VTE compared to older-generation hormonal contraceptives that have lower doses of estrogen.

It is important to note that the U.S. Food and Drug Administration is not required to follow the recommendations of its advisory panels, although it often does.

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